- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250880
Evaluation of Serum Ceramides C16, C24, and Sphingosine-1-Phosphate (S1P) in Patients With Acne Vulgaris (CER-S1P-ACNE)
Acne vulgaris is a common chronic inflammatory skin disorder that affects adolescents and young adults. Recent research has shown that lipid mediators, including ceramides and sphingolipids, play an important role in maintaining skin barrier function and inflammation.
This study aims to evaluate the serum levels of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) in patients with acne vulgaris and compare them to healthy controls. The goal is to explore their possible role in the pathogenesis and severity of acne. Blood samples will be collected from participants, and quantitative analysis will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Study Overview
Status
Conditions
Detailed Description
Acne vulgaris involves complex biochemical and immunologic mechanisms that extend beyond the traditional concepts of follicular obstruction and increased sebum production. Emerging evidence highlights the contribution of systemic lipid mediators-particularly sphingolipids-in influencing keratinocyte behavior, sebaceous gland activity, and inflammatory signaling pathways. Disturbances in circulating ceramides and their downstream metabolites may reflect dysregulated lipid homeostasis that parallels the clinical manifestations of acne.
In this study, specific attention is given to three sphingolipid biomarkers that have been increasingly linked to cutaneous biology: Ceramide C16, Ceramide C24, and Sphingosine-1-phosphate (S1P). These molecules participate in cell differentiation, apoptosis, and immune responses, and their altered levels may provide insight into acne-related metabolic shifts. By quantitatively assessing their serum concentrations in affected individuals and comparing them with healthy subjects, the study aims to characterize potential biochemical patterns associated with disease presence and activity.
All biological samples will be processed using a validated LC-MS/MS analytical platform to ensure precise measurement of each sphingolipid species. The findings may help to clarify whether systemic sphingolipid disturbances contribute to acne pathophysiology and could support the development of lipid-based biomarkers or therapeutic strategies in future dermatologic research.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Study Population:
A. Inclusion Criteria:
For Case Group
This group will consist of (40) patients :
- Both males and females aged 15-40 years.
- Mild, Moderate, severe and very severe cases will be included. 5
For Control Group:
• This group will consist of age- and sex-matched (40) healthy volunteers.
B. Exclusion Criteria (for both groups):
- Presence of any dermatological condition other than acne vulgaris (for cases).
- Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months.
- Pregnancy or lactation.
- History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism
Description
Inclusion Criteria:
- For Case Group
This group will consist of (40) patients :
- Both males and females aged 15-40 years.
- Mild, Moderate, severe and very severe cases will be included. 5
For Control Group:
• This group will consist of age- and sex-matched (40) healthy volunteers.
Exclusion Criteria:
Presence of any dermatological condition other than acne vulgaris (for cases).
- Use of systemic or topical treatment such as isotretinoin or antibiotics within the last 3 months.
- Pregnancy or lactation.
- History of lipid-lowering therapy or supplements affecting ceramide or sphingolipid metabolism.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acne vulgaris patients
Both males and females aged 15-40 years. • Mild, Moderate, severe and very severe cases will be included |
Venous blood samples (5 mL) will be collected from all participants under aseptic conditions.
Serum will be separated and stored at -80°C until analysis.
Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
No therapeutic intervention will be given.
|
|
Healthy controls
Healthy controls Description: Age- and sex-matched healthy volunteers |
Venous blood samples (5 mL) will be collected from all participants under aseptic conditions.
Serum will be separated and stored at -80°C until analysis.
Quantitative estimation of ceramide C16, ceramide C24, and sphingosine-1-phosphate (S1P) will be performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
No therapeutic intervention will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum levels of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P)
Time Frame: At baseline (single visit)
|
Quantitative assessment of serum concentrations of Ceramide C16, Ceramide C24, and Sphingosine-1-Phosphate (S1P) in acne vulgaris patients and healthy controls using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
|
At baseline (single visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-25-10-11MS
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